Rivaban
Generic Name
Rivaroxaban
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivaban 10 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant used to prevent and treat blood clots. It works by directly inhibiting Factor Xa, an enzyme involved in the blood clotting cascade.
Uses & Indications
Dosage
Adults
For VTE prophylaxis after hip/knee surgery: 10 mg orally once daily, starting 6-10 hours post-surgery. Duration: 5 weeks for hip replacement, 2 weeks for knee replacement. For extended DVT/PE treatment: 10 mg orally once daily after at least 6 months of standard anticoagulant treatment.
Elderly
No specific dose adjustment is required based solely on age, but renal function should be assessed.
Renal_impairment
Mild renal impairment (CrCl 50-80 mL/min): No dose adjustment. Moderate renal impairment (CrCl 30-49 mL/min): No dose adjustment. Severe renal impairment (CrCl <30 mL/min): Use with caution or avoid, as rivaroxaban exposure may be significantly increased.
How to Take
Rivaban 10 mg tablets can be taken orally with or without food. It is recommended to take the tablet at approximately the same time each day.
Mechanism of Action
Rivaroxaban selectively and directly inhibits Factor Xa, which is crucial for the coagulation cascade. By inhibiting Factor Xa, it prevents the conversion of prothrombin to thrombin, thus reducing thrombin generation and subsequent clot formation.
Pharmacokinetics
Onset
Within 2-4 hours
Excretion
Approximately two-thirds of the dose is excreted via the kidneys (one-third as unchanged drug, one-third as inactive metabolites). The remaining one-third is excreted via the fecal route, mostly as inactive metabolites.
Half life
5-9 hours in young adults; 11-13 hours in elderly
Absorption
Rapidly absorbed, reaching maximum plasma concentrations 2-4 hours after oral administration. Bioavailability is high (80-100%) for the 10 mg dose.
Metabolism
Metabolized via CYP3A4, CYP2J2, and CYP-independent mechanisms. Approximately 50% of the dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to rivaroxaban or any excipients of the tablet.
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Concomitant use significantly increases the risk of bleeding and is generally contraindicated, except for specific bridging therapies.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease rivaroxaban exposure, potentially reducing efficacy. Concomitant use should be avoided.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Concomitant use increases the risk of bleeding. Use with caution.
Strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir)
May significantly increase rivaroxaban exposure, leading to an increased risk of bleeding. Concomitant use should be avoided.
Storage
Store below 30°C in a dry and dark place, protected from moisture and light. Keep out of reach of children.
Overdose
Overdose of rivaroxaban may lead to an increased risk of bleeding. Management includes symptomatic treatment, supportive measures, and consideration of activated charcoal (if administered soon after ingestion). Prothrombin Complex Concentrates (PCCs) may be used to reverse the anticoagulant effect in severe bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy due to potential fetal harm. It is not recommended during breastfeeding as it is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to rivaroxaban or any excipients of the tablet.
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Concomitant use significantly increases the risk of bleeding and is generally contraindicated, except for specific bridging therapies.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease rivaroxaban exposure, potentially reducing efficacy. Concomitant use should be avoided.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Concomitant use increases the risk of bleeding. Use with caution.
Strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir)
May significantly increase rivaroxaban exposure, leading to an increased risk of bleeding. Concomitant use should be avoided.
Storage
Store below 30°C in a dry and dark place, protected from moisture and light. Keep out of reach of children.
Overdose
Overdose of rivaroxaban may lead to an increased risk of bleeding. Management includes symptomatic treatment, supportive measures, and consideration of activated charcoal (if administered soon after ingestion). Prothrombin Complex Concentrates (PCCs) may be used to reverse the anticoagulant effect in severe bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy due to potential fetal harm. It is not recommended during breastfeeding as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date (refer to product label)
Availability
Pharmacies, Hospitals
Approval Status
Approved (e.g., FDA, DGDA)
Patent Status
Generic available in Bangladesh
Clinical Trials
The safety and efficacy of rivaroxaban have been established through extensive clinical trials, supporting its use in various thromboembolic conditions. Ongoing trials continue to explore new indications and patient populations.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT, INR) is generally not required for efficacy, but can be performed to assess the presence of rivaroxaban.
- Hemoglobin and hematocrit should be monitored if bleeding is suspected or in high-risk patients.
- Renal function (creatinine clearance) should be assessed periodically, especially in elderly patients or those with kidney impairment.
- Liver function tests may be monitored if liver dysfunction is suspected.
Doctor Notes
- Emphasize patient education on bleeding signs and symptoms and the importance of immediate reporting.
- Assess renal and hepatic function periodically, especially in elderly and high-risk patients.
- Counsel patients on potential drug interactions, especially with strong CYP3A4 inhibitors/inducers and other anticoagulants/antiplatelets.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor; do not stop taking it without consulting your doctor.
- Be aware of signs of bleeding (e.g., unusual bruising, prolonged bleeding from cuts, blood in urine or stool) and report them immediately to your doctor.
- Inform your doctor or dentist that you are taking Rivaban before any surgery or dental procedure.
- Avoid activities that may lead to injury and bleeding.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. Do not take two doses at once to make up for a missed dose. Continue with your next dose as scheduled.
Driving Precautions
Rivaban may cause dizziness or fainting in some patients, which could affect the ability to drive or operate machinery. Patients should exercise caution until they know how the medicine affects them.
Lifestyle Advice
- Avoid excessive alcohol consumption, as it may increase the risk of bleeding.
- Maintain good oral hygiene to prevent gum bleeding.
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